NCT05003531

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 23, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2023

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

August 5, 2021

Last Update Submit

January 23, 2024

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16

    PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

    Week 16

Secondary Outcomes (11)

  • Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16

    Week 16

  • Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16

    Week 16

  • Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16

    Week 16

  • Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16

    Week 16

  • Change from Baseline in Dermatology life quality index(DLQI) at week 16

    Week 16

  • +6 more secondary outcomes

Study Arms (5)

IBI112 dose 1

EXPERIMENTAL

Participants will receive IBI112 dose 1 subcutaneous injection(SC)

Drug: IBI112 dose 1

IBI112 dose 4

EXPERIMENTAL

Participants will receive IBI112 dose 4 subcutaneous injection(SC)

Drug: IBI112 dose 4

IBI112 dose 2

EXPERIMENTAL

Participants will receive IBI112 dose 2 subcutaneous injection(SC)

Drug: IBI112 dose 2

IBI112 dose 3

EXPERIMENTAL

Participants will receive IBI112 dose 3 subcutaneous injection(SC)

Drug: IBI112 dose 3

Placebo

PLACEBO COMPARATOR

Participants will receive placebo subcutaneous injection(SC)

Drug: placebo

Interventions

IBI112 dose 2DRUG

Participants will receive placebo or dose 2 IBI112 SC

IBI112 dose 2
IBI112 dose 4DRUG

Participants will receive placebo or dose 4 IBI112 SC

IBI112 dose 4
IBI112 dose 1DRUG

Participants will receive placebo or dose 1 IBI112 SC

IBI112 dose 1
IBI112 dose 3DRUG

Participants will receive placebo or dose 3 IBI112 SC

IBI112 dose 3
placeboDRUG

Participants will receive placebo SC

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
  • Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)

You may not qualify if:

  • History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
  • Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23within 6 months of the first administration of study agent
  • Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
  • Has received any conventional therapeutic agent within 1 months of the first administration of study agent
  • Has received any topic therapeutic agent within 2 weeks of the first administration of study agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PeKing University People's Hostpital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 12, 2021

Study Start

September 23, 2021

Primary Completion

March 25, 2022

Study Completion

January 17, 2023

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)